MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for LUCEA ARD568602971 manufactured by Maquet Sas.
[187919157]
Getinge became aware of an issue with one of the lucea 10 light devices. It was reported to us initially that a horizontal tube's weld was faulty and coming off from the vertical tube, which could consequently lead to detachment from the main tube. There was no injury reported, however we decided to report the issue based on the received indication and in abundance of caution - as a situation in which a suspension arm would actually detach may lead to serious injury. It was established that when the event occurred, the light did not meet its specification as it has been found that breakage of the weld occurred? And this confirms that there was technical deficiency of the device (out of specification) and it contributed to event. In the time when the event occurred the device was not used for patient treatment. The device involved in this event has been identified as a lucea 10 model with the serial number (b)(4) and catalog number ard568602971. The manufacturing date of the device is 19th of june, 2017. Device history record was reviewed and no anomalies were found. During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death. Performed evaluation of returned parts revealed that although the cylinder pin, preventing the tube from falling out, was in its dedicated place however it has been broken in two places, what resulted in its function to be lost. This, in the worst case scenario, could cause the tube being completely uncoupled from the main axis and prevented from falling only by the harness cable. The root cause analysis was performed by the subject matter expert and supported with review of faulty parts received from the market. The conclusion is pointing to misuse being the main cause of pin breakage. When the arm of the device (oriented 90o to the main arm) is moved without loosening the clamping knob to release the pivot as described in the user manual nu_lucea_1001701 page 29 (positioning the light), a strong shearing effect is applied on the cylinder pin. With repetitive motions like this over time, it is probable that the pin can break. We believe that this type of our devices are performing correctly in the market. We also believe that if the manufacturer recommendation as described in the instructions for use and pertaining to avoidance of collisions and checks before use would have been followed the incident could have been avoided. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[187919158]
Getinge became aware of a customer product complaint describing deficiency found during the preventive maintenance activities. The allegation was for a horizontal tube's weld found faulty and coming off from the vertical tube. Provided photographic evidence were in line with this description. We were able to confirm that no parts detachment occurred and that the pin was still in place. Our experience shows that in some instances, the pin could be still in place however it could be broken inside the tubing resulting in the function being not fulfil. We were not able to confirm the pin condition, thus we assumed the worst case scenario and possibility that the pin could have been broken inside the tubing. The complaint was therefore decided to be reportable to competent authorities based on the potential and in abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2020-00046 |
| MDR Report Key | 9888565 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-07-09 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2017-06-19 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PASCAL JAY |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET SAS |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUCEA |
| Generic Name | DEVICE, MEDICAL EXAMINATION, AC POWERED |
| Product Code | KZF |
| Date Received | 2020-03-27 |
| Model Number | ARD568602971 |
| Catalog Number | ARD568602971 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |